Category: Outsourcing manufacturing

  • What Ensures Safety in Dietary Supplement Manufacturing?

    What Ensures Safety in Dietary Supplement Manufacturing?

    The regulation of dietary supplements plays a vital role in safeguarding consumer health and ensuring the safety and quality of these products. Dietary supplements encompass a wide range of products, including vitamins, minerals, herbs, and other substances. In this article, we will explore the importance of regulatory oversight in the dietary supplement industry and how solutions like SGS Digicomply can support compliance and enhance safety.

    • Regulatory Framework:

    The regulation of dietary supplements varies across countries, but it typically involves a combination of legislation, guidelines, and oversight by regulatory authorities. These regulations aim to ensure that dietary supplements are safe, properly labeled, and manufactured under quality control standards. Regulatory frameworks help protect consumers from potential risks associated with mislabeling, contamination, or misleading claims.

    • The Demand for ‘Absolute Safety’:

    Consumers often demand assurance of “absolute safety,” which of course is unattainable. Safety can only be evaluated in the context of the use of the product, and any conclusion on the safety of dietary supplements must be based on sound and credible scientific evidence. Whether categorized as dietary supplements, natural health products or food supplements, these products are variously regulated across different jurisdictions worldwide. However, mandatory regulatory requirements aside, with the steadily increasing interest in dietary supplements and the plethora of scientific data being generated to support the potential benefits of various supplement ingredients, the underlying common thread that supports the use of these products is safety.

    • Safety and Quality Standards:

    Regulatory agencies set safety and quality standards for dietary supplements, including requirements for good manufacturing practices (GMPs), quality control testing, and product labeling. These standards help ensure that dietary supplements are produced in a consistent and controlled manner, minimizing the risk of contamination, adulteration, or substandard ingredients.

    Considerations in Evaluating Safety:

    Of key importance for evaluating safety is the concept of the dose-response relationship. This relationship allows for a quantitative assessment of safety and is grounded in the simple underlying principle that “the dose makes the poison.” Without question, adverse effects can occur as a consequence of over-exposure to any dietary constituent. As a result, it is crucial to determine the dose that results in an adverse effect. 

    • Labeling and Claims:

    Regulatory oversight includes requirements for accurate and truthful labeling of dietary supplements. This includes providing clear information about the ingredients, recommended dosage, and any potential allergens. Regulatory agencies also monitor claims made by dietary supplement manufacturers to prevent misleading or unsupported statements that could misinform consumers.

    • Heavy metals, residual solvents, adulterants, contaminants:

    The levels of heavy metals and residual solvents, as well as ingredient-specific contaminants (e.g., pyrrolizidine alkaloids, and aflatoxins), should be controlled in both raw materials and finished products. They should also be evaluated for safety in the target consumer population of that dietary supplement.

    • Adverse Event Reporting:

    Regulatory agencies often establish mechanisms for reporting and monitoring adverse events associated with dietary supplements. This allows for the identification of potential safety concerns and the implementation of appropriate actions to protect public health. Timely reporting and investigation of adverse events contribute to ongoing surveillance and risk assessment within the dietary supplement industry.

    Keep in Mind:

    • Consult your healthcare provider before taking dietary supplements to treat a health condition.
    • Get your healthcare provider’s approval before taking dietary supplements in place of, or in combination with, prescribed medicines.
    • If you are scheduled to have any type of surgical procedure, talk with your healthcare provider about any supplements you take. 
    • Keep in mind the term natural doesn’t always mean safe. Some all-natural botanical products, for example, comfrey and kava, can harm the liver. A dietary supplement’s safety depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the amount you take. 
    • Before taking any dietary supplement, use the information sources listed in this fact sheet and talk to your healthcare providers to answer these questions:
      • What are its potential benefits for me?
      • Does it have any safety risks?
      • What is the proper dose to take?
      • How, when, and for how long should I take it? 

    References:

  • 8 Herbal Products Manufacturing Challenges & Solutions

    8 Herbal Products Manufacturing Challenges & Solutions

    Introduction

    In the dynamic world of herbal products, manufacturers face unique challenges that can impact product quality, consistency, and marketability. Ayurvedic contract manufacturing and herbal cosmetic manufacturers understand these challenges intimately and have developed innovative solutions to address them.

    World Herbal Industry

     • Herbal Product Market: USD 80 billion

     • Annual Growth Rate: 7% 

    • By 2050 will reach 6 trillion 

          -Source: EXIM Bank Report

    The process of manufacturing requires concrete planning, strategizing, and execution to carry out the production process successfully. A series of tasks and processes are involved under the manufacturing hood which includes research and development, huge investments, maintaining stocks and resources, scaling, packaging, technicality, certifications, licensing, etc. To skip these and various other challenges faced during the manufacturing process it is advisable to get associated with a reputed and trusted Contract manufacturer for the production of your herbal products that will help you outshine and uplift your ayurvedic business.

    A few common challenges that are encountered during the manufacturing process but are seamlessly taken care of by a contract manufacturing company include:

    1) Requirement for Skilled Labour

    Challenge: Production processes are long and tedious and require skills and knowledge. It is one challenge that is most commonly faced by all manufacturers whether it is a bulk manufacturing or a small workshop.

    Solution: Contract manufacturers have contacts and connections that allow them to get skilled labor on board. Conduction of training programs by senior staff members and skilled labor can come in handy during such times to help freshers develop their skills thus mutually benefiting the community as well as meeting the gap of lack of skilled labor.

    2) Market and Consumer Trends

    Challenge: The change in market trends due to changing consumer needs can bring about a lot of fluctuations and challenges in the manufacturing segment.

    Solution: To meet this challenge, contract manufacturers often design short-term contracts to be able to save on material costs and avoid losses for the investor at the same time. With changes in market trends, it is essential to change the scale of production which can always be mentioned during the contract framing. Manufacturers study market trends using R&D to help retailers and distributors build trustworthy and reliable brands using their latest and high-quality products.

    3) Inventory

    Challenge: Inventory management is one of the most critical aspects of running a successful business. Keeping an accurate inventory can be quite haunting when it comes to bulk orders and production.

    Solution: Contract manufacturers keep an account of product requirements, specifications, and details to tailor-make the best possible outcome. This leads to efficient inventory management that allows them to supply orders and meet committed deadlines.

    4) Increased Risks

    Challenge: Selling directly to the consumers can involve a greater risk as it eliminates the middleman and puts the entire responsibility of manufacturing processes, marketing, supply chain management, research, and development on one shoulder. This can affect the business in the long run as an impact of change in market trends.

    Solution: Contract manufacturing enables the manufacturing unit to practice its expertise at full capacity while allowing the retailers to primarily focus on marketing and selling the products.

    5) Scalability

    Challenge: This is one of the greatest challenges faced during the DIY manufacturing process as changing the type or upgrading the scale during in-house production can be quite a task for it may require further investment in machinery and equipment.

    Solution: Contract manufacturing allows retailers to upscale the required quantity, design, or product type. The manufacturing unit can easily make the necessary changes in quantity, type, or quality, as per the retailer’s requirements due to the availability of equipment, labor, and resources.

    6) Upkeep and Maintenance

    Challenge: Maintenance and upkeep of machinery and equipment can be quite an expensive affair. With the increase in production, the costs of maintenance also go up due to the increased wear and tear.

    Solution: Contract manufacturers ensure regular maintenance and care of their equipment and machinery to ensure the high quality and consistency of the products.

    7) Automation

    Challenge: Keeping an account and track of all the processes involved in manufacturing can be quite daunting and exhausting but is extremely critical to a business’s success. It is extremely crucial to ensure that the manufacturing processes and operations are accurately executed which often calls for technological advancements and solutions.

    Solution: To ensure this, the contract manufacturers rely on technological advancements, artificial intelligence, and software which allows the company to meet and fulfill market demands and needs with high-quality and accurate products.

    8) Return On Investment

    Challenge: Every business enterprise aims to back greater ROI. In small-scale manufacturing, the production costs are high and are difficult to meet which leads to a low ROI.

    Solution: Contract manufacturing allows retailers to outsource herbal products in the required quantity, whether large or small without having to worry about any production costs. Contract manufacturers on the other hand manufacture goods in bulk for different firms and retailers which allows them to back greater and higher ROI due to low production costs.

    References: